A prospective, interventional, open-label, non-randomized, two-arm, parallel, clinical safety, efficacy and in-use tolerability study of the two test products in healthy adult human subjects having hair fall complaints (alopecia i.e. more than 100 hairs fall per day).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of the test products in terms of
研究概览
简要总结
This is prospective, interventional, open-label, non-randomized, two-arm, parallel, clinical safety, efficacy and in-use tolerability study the test products in healthy adult human subjects having hair fall complaints.
A total of 60Subjects (30 subjects/arm) healthy adult male and non-pregnant |non-lactating females will be enrolled the study.
The total duration of the study will be 90 days from the enrolment.
Visit 01 (Day -04)Screening, tattoo creation and hair growth rate measurement
Visit 02 (Day 01)Enrolment, Baseline evaluation
Visit 03 (Day 45 +2 Days)product usage period and evaluations
Visit 04 (Day 87 +2 Days)Tattoo creation and Evaluations
Visit 05 [Day 90]Evaluation and End of study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 18 to 55 years (both inclusive) at the time of consent.
- •Sex: Healthy non-pregnant/non-lactating females.
- •Females of childbearing potential must have a self-reported negative pregnancy test.
- •Subject are generally in good health.
- •Subject with more than 100 hair fall per day.
- •Subject with self-assessed complaint of thinning of hair.
- •Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
- •If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence).
- •Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
- •If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study.
- •Subjects are willing to give written informed consent and are willing to follow the study procedure.
- •Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil), any other hair growth hair products or hair colour or dye, other than the test products for the entire duration of the study.
排除标准
- •History of any dermatological condition of the scalp other than hair loss.
- •History of prior use of hair growth treatment within 3 months.
- •History of any prior hair growth procedures (e.g., hair transplant or laser).
- •Subjects who have applied topical treatment for hair loss for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study.
- •Subject who perform any salon treatment on hair including haircut during the study period.
- •History of alcohol or drug addiction.
- •Subjects using other marketed hair fall control and/or hair growth products during the study period.
- •Subjects who have plans of shaving scalp hair during the study.
- •Subjects who are on chronic oral steroids 03 months before initial application and during the study period.
- •History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
- •Subjects having a history or present condition of an allergic response to any cosmetic products.
- •Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
- •Pregnant or breastfeeding or planning to become pregnant during the study period.
- •History of chronic illness which may influence the cutaneous state.
- •Subjects participating in other similar cosmetics, devices or therapeutic trials or hair/scalp care products within the last four weeks.
结局指标
主要结局
To evaluate the effectiveness of the test products in terms of
时间窗: Day 04 before Day 01, Day 01, and after test product usage on Day 45, Day 87 and Day 90
1.change in hair growth rate from baseline before and after usage of the test
时间窗: Day 04 before Day 01, Day 01, and after test product usage on Day 45, Day 87 and Day 90
products.
时间窗: Day 04 before Day 01, Day 01, and after test product usage on Day 45, Day 87 and Day 90
2. change in hair density, hair thickness from baseline before and after usage of the
时间窗: Day 04 before Day 01, Day 01, and after test product usage on Day 45, Day 87 and Day 90
test products.
时间窗: Day 04 before Day 01, Day 01, and after test product usage on Day 45, Day 87 and Day 90
3.change in hair length from baseline before and after usage of the test products.
时间窗: Day 04 before Day 01, Day 01, and after test product usage on Day 45, Day 87 and Day 90
4. change in hair fall reduction from baseline before and after usage of the test products.
时间窗: Day 04 before Day 01, Day 01, and after test product usage on Day 45, Day 87 and Day 90
次要结局
- To evaluate the effectiveness of the test products in terms of(1.change in hair root strength and scalp condition and A:T ratio.)
研究者
Dr Nayan Patel
NovoBliss Research Private Limited